21st century formulations - skin md shielding lotion (44099-011) delist 03, 04 & 05

21st century formulations - skin md shielding lotion (44099-011) delist 03, 04 & 05.
SPL v7
SPL
SPL Set ID e809e1d3-0a6d-730d-e053-2a95a90aedb9
Route
topical
Published
Effective Date 2020-11-20
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
octinoxate (7 mg) octisalate (5 mg) homosalate (3 mg)
Inactive Ingredients
cyclomethicone 5 dimethicone methyl gluceth-20 arnica montana flower comfrey leaf chamomile achillea millefolium chondrus crispus .alpha.-tocopherol acetate sorbitan monooleate 1,2-hexanediol caprylyl glycol butylene glycol aminomethylpropanol phenoxyethanol carbomer copolymer type a (allyl pentaerythritol crosslinked) dimethicone/vinyl dimethicone crosspolymer (soft particle) bis-hydroxyethoxypropyl dimethicone (37 cst) aloe vera leaf

Identifiers & Packaging

Marketing Status
otc monograph drug active Since 2008-08-19 Until 2025-11-30

Purpose

Sunscreen

Description

Octinoxate 7% Octisalate 5% Homosalate 3%


Medication Information

Warnings

For external use only.

Uses
  • Helps prevent sunburn.
  • Decreases the risk of skin cancer and early aging caused by the sun.
Purpose

Sunscreen

Directions
  • Apply liberally 15 minutes before sun exposure.
  • Reapply at least every 2 hours.

    Spending time in the sun increases your risk of skin cancer and early skin aging.

Other Information
  • Protect this product from excessive heat and direct sun.
Inactive Ingredients

Water (aqua), Aloe Barbadensis Leaf Extract (Aloe Vera), Cyclopentasiloxane, Dimethicone, Methyl Gluceth-20, Extracts of Arnica Montana Flower (Arnica), Symphytum Officinale Leaf (Camfrey), Chamomilla Recutita (Matricaria Chamomile), Achillea Millefolium (Yarrow), Chondrus Crispus (Carrageenan), Tocopheryl Acetate (Vitamin E), Sorbitan Oleate, 1,2 Hexanediol, Caprylyl Gylcol, Butylene Glycol, Aminomethyl Propanol, Phenoxyethanol (preservative), Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Dimethicone/Vinyl Dimethicone Crosspolymer, Bis-Hydroxyethoxypropyl Dimethicone.

Description

Octinoxate 7% Octisalate 5% Homosalate 3%

Questions?

Call toll free 1-800-540-4790

®2013 Made in USA

21st Century Formulations

Beverly Hills, CA 90210

www.skinmdnatural.com

Section 51945-4

Do Not Use

on damaged or broken skin

Active Ingredients

Octinoxate 7%

Octisalate 5%

Homosalate 3%

When Using This Product

keep out of eyes. Rinse with water to remove.

Stop Use and Ask A Doctor

if rash occurs.

Keep Out of Reach of Children.

If product is swallowed, get medical help or contact a Poison Control Center right away.


Structured Label Content

Warnings

For external use only.

Uses
  • Helps prevent sunburn.
  • Decreases the risk of skin cancer and early aging caused by the sun.
Purpose

Sunscreen

Directions
  • Apply liberally 15 minutes before sun exposure.
  • Reapply at least every 2 hours.

    Spending time in the sun increases your risk of skin cancer and early skin aging.

Other Information (Other information)
  • Protect this product from excessive heat and direct sun.
Inactive Ingredients (Inactive ingredients)

Water (aqua), Aloe Barbadensis Leaf Extract (Aloe Vera), Cyclopentasiloxane, Dimethicone, Methyl Gluceth-20, Extracts of Arnica Montana Flower (Arnica), Symphytum Officinale Leaf (Camfrey), Chamomilla Recutita (Matricaria Chamomile), Achillea Millefolium (Yarrow), Chondrus Crispus (Carrageenan), Tocopheryl Acetate (Vitamin E), Sorbitan Oleate, 1,2 Hexanediol, Caprylyl Gylcol, Butylene Glycol, Aminomethyl Propanol, Phenoxyethanol (preservative), Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Dimethicone/Vinyl Dimethicone Crosspolymer, Bis-Hydroxyethoxypropyl Dimethicone.

Questions?

Call toll free 1-800-540-4790

®2013 Made in USA

21st Century Formulations

Beverly Hills, CA 90210

www.skinmdnatural.com

Section 51945-4 (51945-4)

Do Not Use (Do not use)

on damaged or broken skin

Active Ingredients (Active ingredients)

Octinoxate 7%

Octisalate 5%

Homosalate 3%

When Using This Product (When using this product)

keep out of eyes. Rinse with water to remove.

Stop Use and Ask A Doctor (Stop use and ask a Doctor)

if rash occurs.

Keep Out of Reach of Children. (Keep out of reach of children.)

If product is swallowed, get medical help or contact a Poison Control Center right away.


Advanced Ingredient Data


Raw Label Data

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